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Evaluation of 68-GaNOTA-Anti-HER2 VHH1 Uptake in Brain Metastasis of Cancer Patients

Recruiting
18 years of age
Both
Phase 2

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Overview

This study investigates the uptake of the radiopharmaceutical 68-GaNOTA-Anti-HER2 VHH1 in brain metastasis using PET/CT imaging. Patients with HER2-positive and HER2-negative cancer will be included and the uptake in their lesions will be compared.

Optional 68-GaNOTA-Anti-HER2 VHH1 scans may be performed during or after treatment, at time points 12±6 weeks and 24±9 weeks after the first scan.

Eligibility

Inclusion Criteria:

  • Patients who have given informed consent
  • Age 18 years or older
  • Patients with brain metastasized cancer, with at least 1 brain lesion of at least 8 mm maximal diameter, as measured by CT or MRI.
  • Patients with potentially HER2-positive cancer. Either a HER2 staining should have been done in standard of care, or sufficient tissue should be available for HER2-staining for study purpose.

Exclusion Criteria:

  • Pregnant patients
  • Breast feeding patients
  • Patients with recent (< 1 week) gastrointestinal disorders with diarrhea as major symptom
  • Patients with any serious active infection
  • Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the test radiopharmaceutical
  • Patients who cannot communicate reliably with the investigator
  • Patients at increased risk of death from a pre-existing concurrent illness

Study details

Carcinoma, Receptor, ErbB-2

NCT03331601

Universitair Ziekenhuis Brussel

29 April 2024

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